A new state-of-the-art, Advanced Therapies Contract Development and Manufacturing Organization (CDMO), located in Bilbao, Spain, is looking for a GMP Manufacturing
Manager.

Key duties /Responsibilities:

• Manage, develop, and lead a team of skilled professionals.
• Manage the GMP manufacturing facility to meet established delivery schedules and the company's stringent quality standards.
• Support a culture of operational excellence where teamwork and active problem solving lead to continuous improvement throughout the organization.
• Ensure that team activities, equipment, facilities, and personnel are operated and maintained in a state of compliance with appropriate requirements.
• Defend his/her area of responsibility in regulatory or customer audits.

Minimum Qualifications:

• University degree.
• 8-10 years of experience in a pharmaceutical/biotechnology GMP environment.
• 3+ years of experience supervising a team in a bio/pharmaceutical cGMP operating environment.
• Expertise in one or more of the following areas: chromatography (ÄKTA process systems), tangential flow filtration or sterile filtration.
• Experience in commercial scale cGMP operations, deviation handling, GMP change control and validation.
• Familiarity with advanced therapy products is a plus.
• Experience in defending and managing audits, including those conducted by regulatory agencies such as EMA and FDA, as well as customer-initiated audits.
• Flexible enough to adapt to a growing organization and diverse client needs.
• Proven ability to innovate and drive continuous improvement.
• Ability to build and lead high performing teams and be a strong team player.
• Strong organizational skills.
• Ability to solve practical problems and deal with a variety of variables.
• Good communication skills.
• Fluent in English and Spanish.

We offer:

• Join a new CDMO with a unique, disruptive technology in a high-growth market.
• Help build a high-performance organization.
• Initiate and optimize GMP manufacturing activities.

Cima is a translational research institute of the University of Navarra, based in Pamplona, Spain.
Selected candidate would lead a team, with the goal to discover new molecules, against novel targets or mechanisms of action discovered by Cima, to become therapeutic agents that might address unmet medical needs.

Main Responsibilities:

• Participate in the Steering Committee, responsible for the internal scouting process to identify projects with small molecules, with potential for early development and optimization.
• Coordinate the full drug discovery process, once a new target or mechanism of action has been discovered, until a new family of molecules has been patented.
• Confirmation of the validity, in vitro and in vivo, in terms of efficacy and safety of the new molecules and targets or mechanisms of action of clinical interest.
• The selected professional will be directly responsible for the design of the families of target molecules.
• Will participate in the coordination of all the teams and tasks involved in the drug discovery process, such as:
  a. Obtaining and expressing target proteins.
  b. Biochemical and biophysical assays between targets and ligands.
  c. Design of the families of molecules.
  d. Computational studies, including studies with artificial intelligence.
  e. Supervision of the CRO in charge of the synthesis of molecules.
  f. Management of all regulatory preclinical, PK-PD, ADMET studies.
  g. IP coordination.
• Lead the drug design process.

Required Qualifications & Experience:

• Participate in the BD and IP committees.
• Ph.D. in chemistry or pharmacy with postdoctoral training in medicinal chemistry.
• 10+ years of drug discovery experience.
• 6+ years of drug design experience and should have detailed knowledge of the drug discovery process.
• Additional experience in computational and AI studies will be an asset.
• Track record of patented molecules.
• Ability to work cross-functionally with a variety of departments, functions and stakeholders.
• Strong persuasion and negotiation skills.
• Effective communication of project status, science, and strategy to a variety of internal and external audiences.
• Fluency in English is a must, Spanish is preferred.

Our client, Vall d’Hebron Institut Oncology (VHIO), reference center in personalized Medicine in Oncology and managing more than 500 clinical studies, is currently looking for a Clinical Trials Office Director. The successful candidate will lead the clinical trials office and will participate in translational research projects at VHIO. This position is located in Barcelona.

 Responsibilities

• Responsible for planning, coordination, and management of clinical trials office (Start-up team, study coordinators, data entries).
• Oversee clinical coordination, data management, regulatory and compliance activity of clinical trials.
• Supervision of key indicators of Clinical Trials activity.
• Maintain regular meetings with sponsors, CROs and PI to improve clinical trials execution.
• Maintain effective collaborations with internal and external stakeholders.
• Develop of operational strategies to optimize clinical trials execution.
• Collaborate and interact with internal team leaders and cross-functional teams.
• Assure that CTO staff is trained and follow standard operational procedures.
• Assist Principal Investigators in investigator’s-initiated trials.

Requirements & Experience

• Degree or PhD in life sciences or field associated with clinical research.
• Knowledge and experience in clinical trials in multiple phases in Oncology and Hematology.
• Successful experience recruiting, supervising, training, developing and managing staff within a team.
• Demonstrated experience in clinical trial management.
• Fluency in written and spoken English and Spanish is required.
• Fluency in written and spoken Catalan is a plus.
• Excellent interpersonal skills including the ability to establish and maintain effective working relationships.
• A collaborative and flexible approach with evidence of ability to lead teams, work independently and work as part of a team.

The offer

• Permanent contract in a full-time position.
• Flexible working hours and measures to balance work, family, and personal life, and promote gender equality, as established in the VHIO collective agreement.
• Flexible remuneration program (includes restaurant vouchers/cards, transport, medical insurance, and “daycare” voucher).
• 23 days of holidays and 5 personal days.
• Access to VHIO’s personal development and training plan.
• Being part of a center that is constantly developing, highly competitive, seeking excellence in research and collaborating with leading teams.
• We offer and promote a diverse and inclusive environment and welcome all people equally, regardless of age, disability, gender, nationality, race, religion, or sexual orientation.

Our client is a clinical-stage biotech developing CAR-T candidates based on multiple antigens for different oncological indications, and an allogenic platform based on Gamma delta T cells coming from a novel source. The company, a spin-off from an international top-notch leukemia researchcenter, has already raised more than 15 million €€ pre-Series A from VCs as well as non-dilutive funds to advance its pipeline programs.

Main responsibilities:

• Financial Round:
  o Define fundraising strategy for Series A.
• Business development activities:
  o Attendance to partnering events and congresses.
  o Contacts with VCs, pharmas, corporate investors.
  o Deal making, i. e. licensing of specific assets.
• Strategy definition and implementation
  o Clinical strategy.
  o Pipeline extension.
• Execution of the Development plan:
  o Follow-up meetings and review reports from institutions.
  o Negotiate contracts for outsourcing activities.
  o Establishment of a preclinical regulatory roadmap.
  o Budget control and execution.
• Professionalization of the Company.
  o Establishment of a SAB (Scientific Advisory Board).
  o Conduct Board meetings.
  o Reporting to Investors.
  o Team building.
  o Corporate image.

Requirements and skills:

• Previous experience in ATMPs, preferably, cell therapy.
• Leadership of small, high-performance teams in fast-moving environments, at C-level or similar.
• Experience in raising funds from international VCs and corporate investors.
• Experience in raising non-dilutive funds.
• Experience in technology transfer projects from research centers.

We are looking for full-time CEO, ideally with residence in or willingness to relocate to Barcelona; if relocation is not feasible, the CEO is expected to be in
Barcelona on an as-needed basis, at least 1-2 weeks per month.

Our client's platform technology enables the efficient delivery of large genes using adeno-associated vectors (AAV). The company overcomes one of the main limitations of AAV, which is their small packaging capacity, allowing the development of treatments for several diseases for which there are currently no treatments. The company has completed the largest Series A financing ever in the Spanish biotech sector.

Our client is looking for a Director of Quality, responsible for establishing and developing quality systems and shaping the quality culture of the organization.

Main Responsibilities:

• Establish a culture of compliance and collaboration through the implementation and improvement of quality processes.
• Oversee and manage all GxP quality functions.
• Lead the development of pharmaceutical quality systems - aligning policies, processes and procedures for internal and outsourced activities.
• Ensure that all outsourced manufacturing activities and product testing are appropriate and conducted in accordance with company policies and GxP standards.
• Ensure quality agreements with key suppliers and partners are complete, approved and updated at appropriate intervals.
• Oversee risk assessments to determine the level of compliance risk. Lead the implementation of appropriate risk mitigation strategies.
• Provide guidance on investigations and corrective and preventive action (CAPA) plans for compliance issues and/or observations.
• Prepare and manage departmental operating plans and budgets.
• Oversee the hiring of staff and external consultants, as well as the training and mentoring of staff.

Required Qualifications & Experience:

• Ph.D. or Master's degree in Biopharmaceutical or related field.
• Minimum of 15 years of progressively responsible experience in the pharmaceutical/biotech industry, including 5+ years leading a quality function in development activities.
• Experience in establishing and/or enhancing the development of GxP quality infrastructure and systems in compliance with EU and US regulations.
• Experience in overseeing GLP and early phase GCP quality programs.
• Experience in overseeing GMP manufacturing of biologics (and preferablyATMPs) in CDMOs.
• Successful track record in managing GCP and GMP inspections.
• Knowledge and experience in negotiating quality agreements and managing supplier relationships and performance.
• Expert knowledge of quality risk assessment and management methodologies, including successful application and risk remediation.
• Strong leadership and interpersonal/communication skills. Demonstrated success in working effectively with senior scientific, medical and operational staff.
• Fluency in English is a must and Spanish is preferred.
• Eligibility (and experience) as an EU Qualified Person is also preferred.
• Relocation to Barcelona is preferred, but a hybrid position is an option.

The CaixaResearch Institute is a new leading international research center promoted by “la Caixa” Foundation. Our purpose is to boost the translational study of Immunology & Diseases and the development of ground-breaking Life Science Technologies, in line with global scientific and societal challenges, including an approach to Exposomic Sciences.

The CaixaResearch Institute vision is to support the best researchers in the field of Immunology by creating a dynamic and engaging environment, with a modern and flexible structure based on transversal research programs carried out through dedicated task forces, with the aim of

Enable an interdisciplinary understanding of immunology.
Meet the evolving needs of the health science community.

Boost translational research.

Main Responsibilities:

• Developing and implementing the CaixaResearch Institute’s knowledge and technology transfer processes, protocols and policies (IP policy, spin-off creation, VC funding, etc.)
• Fostering a culture of innovation within the organization and coordinating the Innovation Hub initiative (in early stages) to impulse innovation in research centers.
• Staying up to date with industry trends, technologies, and best practices related to innovation management.
• Identifying new business opportunities and potential areas for growth and development.
• Developing and maintaining international alliances and partnerships.
• Reporting about the progress and outcomes of the implemented innovation processes.
• Acting as interim research support office for guiding researchers with fundraising.
• Acting as interim project management office (PMO) of the center, facilitating the coordination of the different activities and communication with the different stakeholders.

Required Qualifications & Experience:

• Advanced degree in life sciences or engineering (Master or PhD), ideally combined with MBA or similar.
• 5 years of experience in a similar position.
• Deep knowledge of public and private research and innovation funding schemes (national and international).
• Deep knowledge of IP, tech transfer, spin-out process and policies.
• Solid understanding of project management methodologies.
• Business strategy, market research and analysis.
• Work collaboratively with others to drive innovation.
• Think creatively, communicate effectively.
• Versatile/flexible/resourceful.

We offer:

• Be involved in the creation of a new leading research organization from scratch.
• Impulse the creation of an innovation-based institution.
• Work with top-notch scientists.
• High visibility.

The CaixaResearch Institute is a new leading international research center promoted by “la Caixa” Foundation. Our purpose is to boost the translational study of Immunology & Diseases and the development of ground-breaking Life Science Technologies, in alignment with global scientific and societal challenges, including an approach to Exposomic Sciences.

The CaixaResearch Institute vision is to support the best researchers in the field of Immunology through the creation of a dynamic and engaging environment, with a modern and flexible structure based on transversal research programs operated through dedicated task forces, with the objective to:

• Enable an interdisciplinary understanding of immunology.
• Meet the evolving needs of the health scientific community.
• Boost translational research.

Main Responsibilities:

• Developing and overseeing the technical direction of the CaixaResearch Institute.
• Assessing the center’s current and future technological needs.
• Ensuring the correct definition, implementation, and future management of the center’s scientific-technical infrastructure.
• Recommending and managing the acquisition of any relevant new technology or equipment.
• Managing and coordinating the center’s technical personnel.
• Managing the budget for the purchase, functioning, and maintenance of the center’s scientific-technical infrastructure.
• Establishing and maintaining partnerships with external relevant stakeholders (i. e. other research centers, companies).
• Assisting researchers in correctly assessing their technical needs to facilitate both the planning and implementation of their research projects.
• Supporting and facilitating the proper execution of high-quality, innovative research projects, in compliance with any relevant regulations and standards.
• Ensuring the correct maintenance and upgrading of the center's scientific-technical infrastructure.
• Collaborating with other departments to ensure the smooth functioning of the research center.
• Coordinating the Biomedical Data Hub initiative for the CaixaResearch Institute, currently in early stages, with the objective to improve the management of biomedical data (FAIRification).

Required Qualifications & Experience:

• Advanced degree in life sciences (PhD) or engineering.
• Minimum of 5 years of experience in the management of scientific-technical research infrastructure, preferably in a life science research area.
• Ability to balance the technical demands of specific research projects with the needs of the research center as a whole.
• Familiarity with budget management and resource allocation.
• Ideally, knowledge of life science regulations and standards, including data management protocols.
• Strong leadership and project management skills.
• Ability to work collaboratively with other team leaders and stakeholders.
• Excellent communication and interpersonal skills.
• Strong problem-solving and analytical skills.

We offer:

• Be involved in the creation of a new leading research organization from scratch.
• Impulse the creation of an innovation-based institution.
• Work with top-notch scientists.
• High visibility.

Main responsibilities & purpose:

• Managing and executing clinical and safety pharmacology in the clinical trials including but not to limited to drug-drug interaction, DMPK, PK/PD and non-clinical ADME studies.
• Prepare and edit non-clinical documents for regulatory submission (e.g., IBs, INDs and regulatory briefing documents)
• Support product development with extensive knowledge and understanding of pharmacology pathways and mode of action.

Requirements and skills:

• PhD. in Biological Sciences, Toxicology, Pharmacology
• 6-8 years drug development experience, with minimum 3 years working in industrial pharmaceutical pharmacology/ADME/toxicology/safety/regulatory assessment drug development.
• Proven experience in design, coordination, analysis, and documentation of preclinical studies and in writing position papers on safety, toxicology, and pharmacology.
• Several years of professional experience in medical or scientific writing as well as written and oral communication skills
• Ability to work independently without much supervision.
• Successful experience working in a multicultural environment.
• Flexible, organized, team player, resilient.
• Proactive, independent problem solver, capable to excel in a fast-moving environment.
• Travel on an as-needed basis to investigational sites, conferences, and regulator meetings.
• Creative thinker with excellent communication & problem-solving skills,
• Fluency in English (written and spoken).